MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	NCEUP2520X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material.The balloon material was jagged and uneven at the tear site.Slight deformation was visible to the distal tip.Com code: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a nc euphora ptca balloon catheter to treat a patient's calcified ramus lesion.There was no damage noted to packaging and there were no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues.The lesion was pre-dilated and the device did pass through a previously-deployed stent.The balloon was being used to post dilate the stent that was just placed.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the balloon burst during the first inflation after the physician applied an inflation pressure of 10 atm.The same inflation device was used with other devices pre-or post the inflation difficulties encountered.The device was not moved or re-positioned prior to the burst.There was a sudden drop in pressure noted on the inflation device and no blood came back into the endoflator.The balloon would not hold pressure.No difficulties were encountered when removing the device from the patient.The device was replaced by another manufacturer¿s product.

• Brand Name: NC EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6968054
• Report Number: 9612164-2017-01494
• Device Sequence Number: 1300958
• Product Code: LOX
• UDI-Device Identifier: 00643169396142
• UDI-Public: 00643169396142
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: NCEUP2520X
• Device Lot Number: 213792906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1